FDA

Results from the FDA’s first comprehensive examination of clinical trial enrolment in older patients with blood cancers has revealed that patients over 75 are significantly underrepresented. When looking at the occurrence of these conditions, it has recently been found that one in five patients in the US who are diagnosed with blood cancer are over

In the past few years 3D printing has become the next big trend on the horizon and it has now turned its sights onto the pharmaceutical industry… A few days ago the FDA approved the world’s first 3D printed drug; Aprecia’s Spritam and will be used for treating epilepsy.

US regulatory body, the Food and Drug Administration (FDA), have granted breakthrough therapy status to Bristol-Myers Squibb and AbbVie’s elotuzumab to treat multiple myeloma (MM). The designation has been granted by the FDA for elotuzumab’s use with lenalidomide and dexamethasone in patients who have previously received one or more therapies to treat multiple myeloma. Elotuzumab

Advisors for the US regulatory body, the FDA, have given strong support for the approval of Merck & Co’s bloodthinner drug, vorapaxar. The US regulatory agency’s Cardiovascular and Renal Drugs Advisory Committee yesterday voted 10-1 in favour of vorapaxar being allowed onto the US market as an adjunctive treatment for cutting atherothrombotic events in patients

US regulatory body, the Food and Drug Administration (FDA), have announced that they will be undertaking an accelerated a review of Sanofi’s Genzyme unit’s Gaucher disease drug, Cerdelga (eliglustat), having granted a six-month priority review for the application. Gaucher disease is a genetic disorder where lipids build up in cells and certain organs, causing problems

The US Food and Drug Administration (FDA) announced on Friday that they have approved Auxilium Pharmaceuticals’ Xiaflex to treat Peyronie’s disease, which causes painful, curved erections in men. Xiaflex (collagenase clostridium histolyticum) is the first FDA-approved non-surgical treatment option for men with Peyronie’s disease, who have a plaque in the penis that results in curvature

Johnson & Johnson (J&J) has announced that they have received regulatory approvals on both sides of the Atlantic for Olysio and Invokana. The US regulatory body, the Food and Drug Administration (FDA), approved Olysio (simeprevir) on Friday to treat chronic hepatitis C virus infection. The drug was co-developed with Sweden’s Medivir.

Novo Nordisk has received approval from US regulatory body, the Food and Drug Administration (FDA) for their haemophilia A drug. The regulatory board have approved the Novo Nordisk’s Biologics License Application for Novoeight (turoctocog alfa), a third-generation recombinant coagulation factor VIII.

An advisory panel to the US Food and Drug Administration (FDA) have rejected AbbVie’s Humira (adalimumab) for the treatment of a spinal inflammatory disease. AbbVie are planning to expand the drug’s existing indication for ankylosing spondylitis to include the treatment of non-radiographic axial spondyloarthritis, an inflammatory disease characterised by back pain.

The US regulatory agency, the Food and Drug Administration (FDA), has given the green light to Protein Sciences Corp’s Flublok. The vaccine will be the first trivalent influenza injection made using an insect virus expression system and recombinant DNA technology. Unlike existing vaccines, Flublok does not use the flu virus or eggs; this is due